Memorandum of Understanding Between the Food and Drug Administration and the Environmental Protection Agency

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Memorandum of Understanding Between the Food and Drug

Administration and the Environmental Protection Agency

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice of

a memorandum of understanding (MOU) between FDA and the Environmental

Protection Agency (EPA). This action is necessary to establish the

working arrangements and responsibilities of the two agencies. The

purpose of the MOU is to establish an FDA liaison to the EPA Gulf of

Mexico Program Office.

DATES: The agreement became effective September 29, 1994.

FOR FURTHER INFORMATION CONTACT: Juanita Pointer, Center for Food

Safety and Applied Nutrition (HFS-669), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-205-4098.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which

states that all written agreements and memoranda of understanding

between FDA and others shall be published in the Federal Register, the

agency is publishing notice of this memorandum of understanding.

[[Page 12241]] Dated: February 3, 1995,

Ronald G. Chesemore,

Associate Commissioner for Regulatory Affairs.

Memorandum of Understanding Between U.S. Department of Health and Human

Services, Public Health Service, Food and Drug Administration and

Environmental Protection Agency, Gulf of Mexico Program

Purpose:

This Memorandum of Understanding (MOU) is to establish the

working arrangements and responsibilities of the Food and Drug

Administration (FDA) and the Environmental Protection Agency (EPA)

for the purpose of FDA providing a liaison to the EPA Gulf of Mexico

Program Office.

Background:

The Gulf of Mexico Program (GMP) was established under the

leadership of EPA to develop a comprehensive, intergovernmental

strategy to protect and enhance the environmental quality of the

Gulf of Mexico. The GMP identified priority issues of environmental

degradation and concern, established a Gulf-wide committee framework

and infrastructure to ensure communication and information exchange

and began implementing a 5-year strategy. The strategy includes:

1. Preparation of environmental characterization reports,

2. Preparation of environmental assessments,

3. Development of an interactive data management system,

4. Preparation of predictive assessments,

5. Development of environmental measurement plans and

6. Development of an environmental monitoring system.

FDA's Office of Seafood was established to strengthen the

agency's domestic and imported seafood programs. The Office of

Seafood coordinates all of FDA's seafood activities, including those

which assure that seafood does not contain harmful amounts of

natural or man-made substances, such as toxins, pathogenic

microorganisms, industrial chemicals or toxic metals. FDA uses

several strategies to accomplish its public health mission. One

strategy is to assist EPA in its Gulf of Mexico Program.

A. The Food and Drug Administration agrees to:

1. Assign one individual to serve as the principal liaison

between FDA and the Gulf of Mexico Program (GMP) with responsibility

for managing, coordinating, implementing and evaluating FDA

activities in support of the GMP. The FDA liaison:

a. Provides program and technical assistance and coordination of FDA

activities with the GMP Technical Steering Committee, Policy Review

Committee, technical steering subcommittees and the State, local and

Federal agencies participating in the GMP.

b. Serves as Federal Co-Chair of the Public Health Subcommittee with

primary responsibility for developing a Public Health Action Plan for

the Gulf of Mexico Program and incorporating the recommendations of the

National Academy of Sciences Report on Seafood Safety. The plan should

address four major elements, three of which are problems for which FDA

has the lead:

(1) Illnesses associated with consumption of raw shellfish as a result

of naturally occurring pathogens and/or pathogens of fecal origin.

(2) Risks associated with consumption of Gulf of Mexico seafood

contaminated with toxic substances or pesticides.

(3) Effects of naturally occurring marine biotoxins on the public

health through direct exposure via aerosols and/or exposure via

contaminated Gulf seafood.

(4) Illness associated with recreational or occupational use of ambient

waters contaminated with sewage.

c. Coordinates, with other GMP participants, the five major aspects of

the GMP study: Resource characterization and assessment; problem

identification and study design; communication and education;

integration with ongoing programs of the Gulf; and development of

management, implementation and monitoring strategies.

d. Evaluates technical documents developed by the Technical Steering

Subcommittees and other agencies as they relate to public health and

GMP issues and for consistency with FDA policies, programs and

regulations.

e. Works closely with States to promote cooperation and harmonization

of their public health programs as they relate to Gulf of Mexico

issues.

f. Serves as the FDA point of contact with the National Shellfish

Pollution Indicator Study. Is responsible for keeping the GMP informed

of developments and providing program needs to the Indicator Study

directors.

g. Develops appropriate projects to evaluate programs and methods of

reducing public health risks associated with the use of the waters and

resources of the Gulf of Mexico.

h. Serves as project officer on extramural projects to conduct

scientific studies of interest to FDA which relate to the Gulf of

Mexico Program.

2. Provide the following administrative support to the assigned

individual:

a. Salary--The FDA employee will remain on the FDA payroll for the

entire period of the assignment.

b. Relocation Expenses--The cost of relocating the FDA employee to the

John C. Stennis Space Center, Mississippi, as provided by policies and

procedures relating to reporting to a duty station.

c. Travel Expenses--The FDA employee will be provided transportation

and per diem expenses while in temporary duty status for the entire

period of the assignment.

d. Equipment--FDA will provide a personal computer for use by the

employee during the entire period of the agreement.

3. Provide annual review of the individual's performance for the

entire period of the assignment.

4. Administrative Support--Annually provide partial financial

support to EPA/GMP to defray part of the overall costs to them for

providing services as stated under this IAG. Amount to be worked out

between the two agencies.

B. The Environmental Protection Agency-Gulf of Mexico Program

agrees to:

1. Provide technical supervision and assign day-to-day tasks to

the FDA representative to the GMP. The technical and day-to-day

assignments will be provided by the Director of the Gulf of Mexico

Program; and he shall serve as the EPA's point of contact and the

liaison officer for this interagency agreement.

2. Provide the following administrative support to the assigned

individual:

a. Space--Space will be provided at the GMP Headquarters at the John C.

Stennis Space Center; and the space will contain appropriate furniture

and conveniences.

b. Telecommunication--Telephone service including FTS, Long Distance,

and Fax will be provided.

c. Secretarial Support--Secretarial support will be provided to

include: Typing, xeroxing, dictating, filing, printing, duplicating,

and office supplies.

3. The Director, GMP, will provide FDA with written comments on

the individual's performance for the specified rating period. The

information will be used on the General Workforce Performance

Appraisal of the FDA liaison.

Period of Agreement:

It is anticipated that this MOU will be for approximately 5

years from the date of signature. Modification of the MOU shall be

by mutual consent of the parties. However, if either party desires

to terminate this MOU, a written notice to the other party shall be

forwarded and received 30 days in advance of the desired termination

date.

Approved and Accepted for the Environmental Protection Agency Gulf of

Mexico Program

By: Douglas A. Lipka

Title: Acting Director

Date: September 29, 1994

Approved and Accepted for the Food and Drug Administration

By: Fred R. Shank

Title: Director, Center for Food Safety and Applied

Nutrition [[Page 12242]]

Dated: September 22, 1994.

[FR Doc. 95-5309 Filed 3-3-95; 8:45 am]

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